Drug updated on 4/29/2024
| Dosage Form | Tablet (oral; 200 mg) |
| Drug Class | Kinase inhibitors |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine-based therapy.
- Indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with fulvestrant as initial endocrine-based therapy or following disease progression on endocrine therapy in postmenopausal women or in men.
Summary
- Ribociclib (Kisqali) is indicated for the treatment of adult patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine-based therapy.
- The drug is also used in combination with fulvestrant as initial endocrine-based therapy or following disease progression on endocrine therapy in postmenopausal women or men.
- A total of 11 systematic reviews/meta-analyses were reviewed to compare ribociclib (Kisqali) against other CDK4/6 inhibitors such as palbociclib and abemaciclib, focusing on safety and effectiveness across different population types and subgroup considerations.
- All three CDK4/6 inhibitors including ribociclib (Kisqali), significantly prolong progression-free survival and overall survival rates when combined with fulvestrant or aromatase inhibitors for treating HR+/HER2- advanced/metastatic breast cancer; no significant differences were found among these drugs regarding their effectiveness.
- In terms of safety, ribociclib (Kisqali) showed lower likelihoods of harm for hematological toxicities compared to abemaciclib which exhibited higher occurrences of gastrointestinal effects like diarrhea; however, Kisqali demonstrated a favorable profile managing hematological toxicities but requires consideration due to potential hepatotoxicity risks.
- Palbociclib had the highest likelihoods for dose reductions and discontinuations suggesting better manageability concerning drug-related adverse events while all three drugs reported various dermatological reactions emphasizing the need for adequate management strategies maintaining quality life during treatment adherence process.
- Benefits from using any one out of these three CDk4/6 inhibitors are consistent across postmenopausal women suffering from HR+/HER2- advanced breast cancer regardless whether it's first-line or second-line therapy.
- Older adults, although underrepresented in clinical trials, can effectively tolerate CDK4/6 inhibitors including ribociclib (Kisqali), but careful management and dosing considerations are necessary; abemaciclib may show slightly higher rates of grade 3-4 diarrhea and neutropenia in pre-treated patients.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Kisqali (Ribociclib) Prescribing Information. | 2023 | Novartis Pharmaceuticals Corporation., East Hanover, NJ |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| Early breast cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. | 2024 | Annals of Oncology |
| Breast Cancer, version 3.2020. | 2020 | Journal of the National Comprehensive Cancer Network |